Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03064568

Enrollment

Registered

2017-02-27

Start date

2016-10-14

Completion date

2024-06-18

Last updated

2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myomectomy; Surgical Blood Loss

Keywords

Myomectomy, Misoprostol, Vasopressin, Blood loss

Brief summary

Purpose is to identify if misoprostol in addition to local vasopressin decreases blood loss when compared to vasopressin alone, which is our current practice at this time. The study will be double-blinded with neither the patient nor the researcher knowing whether the placebo or the misoprostol was given. We will monitor patients for decrease in hemoglobin and hematocrit, need for transfusion, and operative time among other measures of perioperative morbidity to see if the addition of misoprostol makes a significant difference. We will also observe patients to see if there are any side effects of misoprostol that make its use undesirable.

Detailed description

All women with planned myomectomy receive Depo Leupron prior to surgery per standard care and undergo routine pre-operative laboratory testing including hemoglobin and hematocrit. If enrolled in the study, patients will be consented at their pre-op appointment for the study and be asked to complete a visual analog scale to assess pre-operative pain. Patients will be randomized to receive misoprostol 800mcg per rectum or an identical inert tablet(s) per rectum 30 minutes preoperatively. Randomization will be performed by a third party so that neither the surgeon nor patient will know which intervention was performed, and interventions will be placed in sealed, sequentially numbered, opaque envelopes. Researcher team will have all needed data corresponding with randomized code which will be broken at conclusion of study and will be able to match code with patient's initials and medical record number after study completion to analyze data. Myomectomy will then be performed per standard care with the use of local vasopressin to aid in decreasing blood loss per our normal standard of care.

Interventions

DRUGMisoprostol 200Mcg Tab

4 tablets will be inserted rectally

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

Randomization to treatment arm done by 3rd party. Randomization will be performed by a third party so that neither the surgeon nor patient will know which intervention was performed, and interventions will be placed in sealed, sequentially numbered, opaque envelopes. The code will only be broken at time of data analysis once all patients have been enrolled.

Intervention model description

Prospective double-blinded study completed at a tertiary care center

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Female age 20-50 y/o who plan to undergo abdominal myomectomy for symptomatic myomatous uterus

Exclusion criteria

* Patient with contraindication to misoprostol or vasopressin, personal history or cardiac or pulmonary disease, history of prior myomectomy

Design outcomes

Primary

Measure	Time frame	Description
Surgical Blood Loss	Intraoperative	Estimated blood loss during surgery

Secondary

Measure	Time frame	Description
Febrile Morbiditiy	24 hours postop	Number of participants that have evidence of fever or infection postoperatively
Need for Blood Transfusion	intraoperative to 24 hours postoperative	Number of participants that had a requirement of blood transfusion
Pain Score	24 hours postop	Assessment of patient subjective pain with the visual analog scale prior to discharge from hospital. The scale used is a a likert pain scale where the participant selects their pain level between 0- 10, where 10 is the highest level of pain experienced.
Number of Participants With Medication Side-effects	24 hours postop	Surveillance for any adverse side effects from misoprostol

Countries

United States

Participant flow

Pre-assignment details

There are no significant pre-assignment procedures beyond standard preoperative care and consent. Before randomization, patients undergo a physical exam, transvaginal ultrasound, receive Depo Leupron, have preoperative hemoglobin and hematocrit testing, and complete a preoperative pain assessment after providing consent.

Participants by arm

Arm	Count
Misoprostol 200Mcg Tab Patients will receive misoprostol 800mcg per rectum 30 minutes preoperatively. Four Misoprostol 200Mcg Tab	8
Placebo Patients will receive identical inert tablets per rectum 30 minutes preoperatively. Placebo	10
Total	18

Baseline characteristics

Characteristic	Placebo	Total	Misoprostol 200Mcg Tab
Age, Customized 20-50 years of age	10 Participants	18 Participants	8 Participants
Race and Ethnicity Not Collected	—	0 Participants	—
Sex/Gender, Customized Female	10 Participants	18 Participants	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 8	0 / 10
other Total, other adverse events	0 / 8	0 / 10
serious Total, serious adverse events	0 / 8	0 / 10

Outcome results

Primary